Electronic Records Handbook

Transcription

1 Electronic Records Handbook

2 Table of contents Key points to consider 3 Introduction 5 Selecting an appropriate system 7 Regulation of electronic records (erecords) 10 Patient consent and rights to access 12 Security and privacy issues 15 Maintaining data integrity 17 Sending and transferring records 22 Destroying and disposing of records 24 Data sharing and inter-physician arrangements 26 Emerging issues 30 Conclusion 34 Appendix A Glossary 35 Appendix B Additional Resources 38 Appendix C Data Sharing Principles 42 Appendix D Contractual Provisions for Data Sharing 53 Appendix E Confidentiality/Non-Disclosure Agreement 63 Disclaimer/Terms of use These learning materials are for general educational purposes only and are not intended to provide professional medical or legal advice, nor represent a professional or legal standard of care for Canadian healthcare providers. Variations in practice are expected and may be appropriate. These suggestions should not be construed as dictating rules for patient care and communicating with patients. Your use of CMPA learning materials is subject to the foregoing as well as CMPA s complete disclaimer found at cmpa-acpm.ca. Canadian Medical Protective Association 2014 Ce document est disponible en franҫais. This document is available on our website at cmpa-acpm.ca 2 Electronic Records Handbook The Canadian Medical Protective Association

3 Key points to consider å Since the regulation of erecords is continually evolving and can be complex, physicians should be familiar with the legislation, regulatory requirements, technological standards, and software options that apply to erecords. For advice and information, doctors may consult with their colleagues; regulatory authority (College); provincial or territorial privacy regulator; provincial, territorial, or national medical association; and the CMPA. See page 5, Introduction. å An erecords system should meet the needs of a physician s practice as well as any applicable legal and regulatory requirements. Advice from a qualified service provider or an experienced user may help physicians in selecting and setting up an EMR. In some cases, physicians may be required by a hospital, regional health authority, or provincial or territorial government to use a specific erecord system (such as an EHR). See page 7, Selecting an appropriate system. å Physicians should consider having an agreement for a shared EMR or EHR. The CMPA s Data Sharing Principles and the template titled, Contractual Provisions for Data Sharing, can be reviewed and serve as a model. An agreement should address issues such as ensuring a physician s continued access to patient records after leaving a group practice or terminating agreements with external service providers. Physicians are also urged to require that their employees and staff members sign a confidentiality or non-disclosure agreement to ensure everyone understands their obligations in keeping patient information secure and confidential. See Appendix C, page 42, Data Sharing Principles; Appendix D, page 53, Contractual Provisions for Data Sharing; and Appendix E, page 63, Confidentiality/Non-Disclosure Agreement. å Physicians should understand their obligations when they participate in an EHR system or when asked to upload portions of their office EMR to an EHR operated by hospitals, regional health authorities, provinces or territories, etc. See page 42, Data sharing and inter-physician arrangements. å Physicians should consider speaking with patients about including personal health information in an erecord. Patients express consent may be necessary when their personal information is shared with others for purposes other than providing healthcare (i.e. outside the circle of care). See page 12, Patient consent and rights to access. Electronic Records Handbook 3

4 å Reviewing the security requirements of erecords should be a priority. This includes ensuring applicable security and secure backup requirements are available, and all personal health information is encrypted. Further, erecords should have an audit trail that can appropriately track if the record has been accessed or altered. erecords should allow physicians to control access to patient information, including having lock-box or masking features if patients request that information be withheld from some healthcare providers. See page 15, Security and privacy issues. å Physicians need to consider appropriate security measures and procedures when communicating personal health information via or other electronic means. See page 22, Sending and transferring records. å Physicians will want to assess the implications of relying exclusively on patient-supplied electronic personal health records (sometimes referred to as patient health records or PHRs ). Doctors should be cautious as patients typically control what information is included in PHRs. If using or accessing personal medical record services, or communicating with patients via portals or websites, physicians will want to discuss any privacy risks with patients. Social media, wireless devices, networks, and cloud computing services must be used with caution. Due to their public or shared nature, there is a potential to lose control of information that is posted or stored. Security and privacy issues must be considered to ensure there is no unauthorized access to, or disclosure of, personal health information. See page 30, Emerging issues. åretention periods for medical records are just as important with erecords as they are for paper records. Once the required retention period for medical records has expired, the information in the erecord can be appropriately destroyed. See page 24, Destroying and disposing of records. 4 Electronic Records Handbook The Canadian Medical Protective Association

5 Introduction Electronic medical records (EMRs) and electronic health records (EHRs) have become an integral part of healthcare delivery in Canada. They can improve the management of individual patient care and bolster the overall effectiveness of the healthcare system. Implementing and using EMRs and EHRs (erecords) can raise a number of technological issues and medico-legal risks. The regulation of erecords continues to evolve and can be complex. Physicians should learn about applicable legislation, regulatory requirements, technological standards, and software options. For advice and information, they might consider consulting with their colleagues, medical regulatory authority, provincial or territorial privacy commissioner (or the equivalent), and provincial or territorial medical association, and with the CMPA. Distinguishing between EMRs and EHRs An EMR generally refers to an electronic version of the traditional paper record that physicians have long maintained for patients. The EMR may be a simple office-based system, but is more likely a sophisticated, shared electronic record accessible to those within a group practice, healthcare facility, or a network of health professionals (e.g. treating physicians, other healthcare providers, information managers, etc.). EHRs are typically maintained by a hospital, health authority, or provincial health ministry and generally include a variety of repositories of patient data. They are usually accessible by several authorized parties from a number of places of care. An EMR is an electronic version of the paper record generally maintained by doctors for their patients. It may be as simple as an office-based system, but is more likely a shared record that connects health professionals through a network. An EHR is maintained by a hospital, regional health authority, or provincial or territorial government and typically includes a spectrum of repositories of patient data. Electronic Records Handbook 5

6 The term erecord refers to the wide range of electronic record management systems available to physicians and other custodians of patient health information. Distinguishing between custodians, information managers, and service providers Under privacy legislation, individuals and entities that have custody and control of personal health information are ultimately responsible for complying with the legislation. In some jurisdictions these individuals and entities are called custodians. In other jurisdictions the legislation may use the terms trustee or organization. For example, a hospital is the custodian of an EHR used in the institution, and physicians are the custodians of the EMR used in their private practice. Custodians responsibilities generally include collecting, using, or disclosing personal health information only with the consent of the patient, or as required or permitted by law. They must also take reasonable steps to maintain the administrative, technical, and physical safeguards that protect the confidentiality of the information. They are responsible for protecting the information from reasonably anticipated threats to its security or integrity, or from loss, unauthorized access, use, disclosure, or modification. Physicians have a professional duty of confidentiality to patients, and this duty is augmented when physicians are also custodians of EMRs. In accordance with the duty of confidentiality, a physician should not disclose confidential patient information unless the patient has consented to the disclosure, or the disclosure is authorized or required by law. Custodians may delegate some or all of their duties under privacy legislation to agents or affiliates. For example, when a physician practises within a hospital or clinic, the facility is the custodian of the personal health information. However, typically hospitals and clinics authorize a physician to act on the institution s behalf for the purposes of assisting it in fulfilling its duties under the applicable privacy statute. If that occurs, a physician will then have similar obligations as the custodian under the applicable privacy legislation. Distinguishing between the responsibilities of custodians and affiliates can be complex. In one context, a physician may be considered to be an affiliate or agent of the hospital or regional health authority that has legal custodianship over the record. For example, when a request is made by a patient or third party for a copy of a medical record, the custodian will generally be responsible for responding to such a request. In other contexts, however, the same physician may also have similar but separate legal and professional obligations to protect the confidentiality of the patient s personal health information. Despite being an affiliate, the physician will generally be expected by privacy commissioners, regulatory bodies, and courts to meet certain obligations when it comes to maintaining patient privacy. Physicians should consider that irrespective of their role as a custodian or affiliate, they have a professional obligation to take reasonable steps to protect the personal health information of patients. In fulfilling their duties, custodians of erecords are often assisted by information managers or third party service providers. A service provider may offer information processing, storage, retrieval, or disposal services; data transformation or information management services; or information technology functions. Some privacy legislation specifies that when engaging a service provider, a custodian must enter into a written agreement. Despite having such an agreement, the custodian remains ultimately responsible for complying with privacy legislation. As a result, if a service provider contravenes an obligation under privacy legislation, it is usually as if the custodian breached the legislation directly. 6 Electronic Records Handbook The Canadian Medical Protective Association

7 Selecting an appropriate system å Access the needs of the practice and choose a system or software program that best meets those needs. å Consider if and how the software program will operate with other erecord systems, both current and future. å Consult with provincial, territorial, or national medical associations, especially those with dedicated ehealth programs and services, which may assist with compliance with provincial regulations and expectations. å Seek professional assistance from the software vendor or an information technology consultant, if appropriate. å Consult with colleagues who have implemented an EMR. å Consult personal legal counsel when dealing with business issues, including equipment leases or purchase agreements. Choosing an electronic record system In choosing an appropriate system, physicians should select a system that meets the needs of their practice, and the legal and regulatory requirements in their jurisdiction. In addition, they should consider how the selected system will operate with other erecords systems. If linking to an EHR, doctors should be aware of compatibility requirements that may be prescribed by health authorities, healthcare institutions, or facilities. To help in making the selection, professional help is available from a variety of sources including technology vendors; information technology consultants; provincial, territorial, or national medical associations; or local physician technical support programs, if available. Colleagues who have implemented an EMR may also provide useful information. Some jurisdictions have a pre-approved vendor list to make the selection process easier and might also provide funding to offset some or all of the acquisition and implementation costs. The system vendor will likely require that the physician or physician group sign a software licence, which is a legal agreement governing the use and distribution of the copyright-protected EMR software. While granting permission to use the software, licence agreements also impose certain obligations and restrictions on the use of the product. Before signing, physicians should be aware of its terms. They are strongly encouraged to contact their personal legal counsel, or provincial, territorial, or national medical association for advice. The system vendor may provide computers, tablets, PDAs (personal digital assistants), servers, or other Electronic Records Handbook 7

8 equipment to be used with the particular erecord system. The equipment might be purchased or leased. If leased, physicians should be aware of the terms of the lease, including any early termination payments or penalties. If purchased, doctors should be familiar with the terms of the purchase agreement including any applicable warranties. Physicians are encouraged to consult their personal legal counsel before entering into any equipment lease or purchase agreement. In addition to choosing the right system (including software and hardware), a number of practical points should be considered including: How will workflow be maintained while the EMR is being installed and records are being converted? How will patient care and record-keeping be managed during the transition stage? What should be done with paper records converted to electronic format or records that are partially converted? Is a privacy impact assessment required? What training will be conducted for physicians and their staff, and who will provide ongoing technical support and training, including during and well after implementation? What processes and pratices will be put in place, both from a technical standpoint and from an office policy point of view, to ensure security and privacy of patient records? How will data integrity be ensured (e.g. audit trails, backup and recovery systems, quality assurance procedures such as audits, etc.)? How will the system be maintained, including making updates and upgrades? How easy is it to input information to the EMR and migrate information to another EMR? How will metadata be protected from being compromised or otherwise changed if data is being migrated? Does the system permit information to be printed for patients in an understandable format? What system will be in place to ensure records are appropriately destroyed after the required retention period? How will physicians continued access to patient information for the applicable retention period be ensured? What are the necessary agreements to be signed? These may include data sharing agreements (agreements setting out the terms for the sharing of electronic health information) with a health authority or government ministry operating an EHR. In addition, agreements may be required with service providers who will offer information technology services. When the EMR is being introduced in a group practice, it may be advisable to have an inter-physician agreement between members of the group. Working with decision support systems Some erecords are equipped with decision support tools embedded in the software that prompt the user to consider certain factors or possible decisions in response to the inputted data. The software may also include alerts, flags, or instant messaging capabilities to assist physicians in diagnosing, treating, and monitoring their patients clinical conditions or managing their prescriptions. A decision support tool in an erecord may present unique and challenging issues that should be considered before buying the system. For example, physicians should determine if the system permits individual users to disable or disregard the decision support tool. If this is the case, doctors will want to consider the availability of a robust audit trail that tracks the advice that is accepted or rejected. Although each system functions differently, users should know in advance how the particular decision support tool operates and whether the information generated is reliable. Decision support tools must not be used to replace a physician s own judgment. Each suggestion offered by the decision support tool should be reasonably considered and assessed based on the circumstances of each case. Physicians will want to consider documenting in the patient s record their reasons for following or ignoring a suggestion provided by the decision support tool or 8 Electronic Records Handbook The Canadian Medical Protective Association

9 for acting on or disregarding an alert, flag, or instant message. If the diagnosis suggested by the software was ignored and proves in hindsight to be accurate, the physician may be required in the course of a legal action or College complaint to justify why the information was disregarded. Similarly, ignored alerts, flags, or messages notifying the physician of abnormal test results or prescription errors could be used as evidence of negligence or professional misconduct in civil or College proceedings. Documentation of the physician s rationale for disregarding a suggestion or notification would be helpful in the event of a College complaint or legal action. Similarly, if the decision support tool is disabled, physicians will want to document their rationale for doing so. Developing and implementing policies When incorporating an erecord system into a medical practice, internal policies should be established to govern issues such as data integrity; consent; security; access; and transfer and destruction of records. In a group practice, policies might be developed as a team to ensure all staff members are engaged in the process and aware of the importance of privacy in the erecord environment. In addition, staff should be appropriately trained to ensure they understand the policies and their obligations. While the details of such policies may vary from practice to practice, it remains vital that in each practice the policies are applied consistently and in keeping with underlying privacy principles. Careful documentation of decisions and the steps that were followed will assist in defending those actions if there is a complaint or civil action. Electronic Records Handbook 9

10 Regulation of electronic records (erecords) å Become familiar with medical regulatory authority (College) requirements, legislation, regulations, or other expectations regarding the use of erecords. å Review privacy legislation as, in some provinces and territories, it may contain specific provisions or expectations regarding erecords. Regulations and guidelines on the creation, maintenance, retention, and destruction of traditional paper medical records generally extend to erecords. As well, additional requirements may apply specifically to records in an electronic format. These will be determined primarily by provincial, territorial, or federal governments, and Colleges. Privacy legislation Privacy legislation governing the collection, use, and disclosure of personal information is applicable in all provinces and territories. In many provinces, the 10 Electronic Records Handbook The Canadian Medical Protective Association

11 legislation includes provisions that apply specifically to the privacy of electronic health records. Legislation governing electronic commerce may also be applicable and typically deems electronic records to be equivalent to paper records, regulates the use of electronic signatures, and addresses other legal requirements. Privacy legislation obliges physicians and other custodians of patient information to take reasonable precautions to minimize the risk of loss, theft, or unauthorized access or use of that information. Some privacy legislation further requires custodians to implement specific safeguards when maintaining patient information in electronic form. Regulatory authority (College) requirements Several Colleges have policies, bylaws, rules, or regulations concerning erecords that include some or all of the following: The system is capable of visually displaying and printing the recorded information for each patient promptly and in chronological order. The system is capable of displaying and creating a printed record in a format that is readily understandable to patients seeking access to their records. The system provides a way to access the record of each patient using the patient s name and medicare health number, if applicable. The system maintains an audit trail that: o o o o o records the date, time, and identity of the user when records are accessed. records the date and time of each information entry for every patient and the identity of the user making the entry. indicates any changes in the recorded information and the identity of the user making the change. preserves the original content of the recorded information when changed or updated. is capable of being printed separately from the recorded information for each patient. The system requires robust security features (including encryption, use of passwords, and access controls) to protect against unauthorized access. The system automatically backs up files and allows the recovery of backed-up files or otherwise provides reasonable protection against information loss, damage, and inaccessibility. While not all of these requirements may apply in every jurisdiction, every jurisdiction has express requirements for the creation and maintenance of medical records that must be followed. Electronic Records Handbook 11

12 Patient consent and rights to access å Consider notifying patients that their health information will be stored in an erecord, even if notification is not strictly required. å Personal health information can generally be shared within the circle of care for the purpose of providing healthcare. (The group of people responsible for providing care to the patient is informally referred to as the circle of care.) å Patients may be permitted to restrict access to their personal health information, for example by using lockboxes, masking, blocking, giving a disclosure directive, or opting-out. å Express consent will often be required when disclosing patient information from an erecord to a third party for purposes other than providing healthcare. å Consider a written agreement with service providers documenting privacy obligations. å When patients request access to their health information that is stored in an erecord, provide it to them in a timely way and in a suitable format. As with any patient information, physicians generally do not need express consent to include patient health information in an erecord, or to share patient information with other healthcare providers for the purpose of providing treatment. Physicians can generally rely on a patient s implied consent to share personal health information within the circle of care, which includes the healthcare professionals who need to know the information to provide care. For example, physicians in a shared call group can rely on a patient s implied consent to exchange personal health information between them for the purpose of providing healthcare to the patient. Privacy legislation also generally permits custodians to share personal health information with an agent or affiliate on the basis of implied consent. This may occur when a physician practising within a healthcare facility that is itself a custodian, is authorized to act on behalf of the facility for the purposes of fulfilling the custodian s privacy obligations. Another example is when physicians hire a service provider (or information manager) to assist with their medical practice. In both of those cases, the custodian remains accountable for the personal health information in the hands of the agent. However, both the agent and the custodian share a professional obligation to adequately protect the information. Members should ensure that hired service providers understand the necessity of protecting personal health information and take the appropriate steps. Members are encouraged to have a written agreement confirming agents understand their obligations. In some jurisdictions, a written agreement is required by privacy legislation or the privacy commissioner. 12 Electronic Records Handbook The Canadian Medical Protective Association

13 Although consent can usually be implied, in some circumstances it may be prudent to notify patients that their health information will be stored electronically, particularly if stored in a shared EMR or an EHR where a number of people have access. Express consent should be obtained whenever a physician is asked to disclose patient information from an erecord: a) to a third party outside of the circle of care, such as an insurer or employer who is not an agent of the physician b) if the information will be used for a purpose other than treating the patient and it is not permitted or required by law Disclosure in the latter case is often referred to as a secondary use of personal health information. Other examples of secondary uses include marketing, conducting research, or providing personal health information to an organization or government body for the purpose of health system planning. Some privacy statutes expressly permit the use of health information for these secondary purposes. Members will want to familiarize themselves with the exemptions in the relevant privacy legislation. When appropriate, patient information should be de-identified as much as possible before being used for purposes other than providing healthcare. When express consent is required, it is generally prudent to ask the patient to execute a consent form. If verbal consent is obtained, it should be documented in the patient s medical record. Regardless of the approach, the patient s consent should be informed. Patients can seek to restrict access to their information by others Patients may ask that access to their health information in an erecord be limited, even if it is for healthcare purposes. This can be done through a process called a lockbox or masking. Physicians with EMRs should consider whether their system permits masking, how they will manage requests for a lockbox or masking, and what their obligations are for informing recipients that the health information may be incomplete. If storing patient information in Electronic Records Handbook 13

14 a shared EMR or an EHR, members should ask those responsible for the shared system how to handle lockbox or masking requests. Some erecord systems may not permit masking of portions of the record, or there may be instances where doing so would be inappropriate. In those instances, consideration might be given to blocking access to the entire record. If a patient has requested that certain information be masked but the EMR software does not have the functionality to do so in the manner requested, this should be explained to the patient, if appropriate, and consent should be obtained before blocking the entire record. Physicians will also want to explain to patients that the masking of some or all personal health information could result in another healthcare professional not being aware of diagnoses, treatments, or laboratory results. These discussions should be fully documented in patients records. In jurisdictions with provincial EHRs, there may be disclosure directive or opt-out processes that permit individuals to control their information. Although the scope and restrictions on the directive or opt-out may vary, they can relate to the type of personal health information contained in the EHR, the purposes for which personal health information may be disclosed from the EHR, and the persons or classes of persons who may access the personal health information in the EHR. Although some jurisdictions require that all prescribed personal health information be uploaded to the EHR, patients may still limit or refuse the use or disclosure of specific information. This can be accomplished by a masking process that blocks the information from being displayed in the EHR when it is accessed by individuals who do not have patients authorization to see the information. When such a disclosure directive or opt-out process exists and is recognized by law, it may restrict a healthcare provider s access to the information, except in certain circumstances such as incapacitation, in an emergency, or with the person s express consent. Patients access to their own health information Patients generally have a right to access their own health information. As a result, physicians must have a way to give patients access to their health information that is stored in an erecord, and the information must be provided in a format that patients can understand. Physicians may charge a reasonable fee for providing copies of records to patients. Despite this obligation, there are circumstances when physicians may be concerned about providing access to certain information. For example, a psychiatrist may believe it would be harmful for a patient to review information related to the psychiatrist s impressions or analysis of the patient s mental health status. In these exceptional circumstances, this concern can be addressed by segregating the potentially harmful information and granting the patient access to the rest of the record. Physicians may wish to consult with their system vendor for information on how to segregate records in this manner. The CMPA can also be contacted for advice on responding to access requests in these circumstances. 14 Electronic Records Handbook The Canadian Medical Protective Association

15 Security and privacy issues å Make sure the erecord system is equipped with robust security features including access controls based on the user s role and responsibilities; automatic logout; and anti-virus, malware, and spyware software. Consult the system vendor or provincial, territorial, or national medical association for assistance in choosing appropriate security features. å Place encryption protection on all computer systems and portable data storage devices containing personal health information. Some privacy commissioners (or equivalent individuals with privacy oversight) and Colleges have stated that physicians and other custodians must encrypt patient information stored on mobile devices. å Consult with the privacy commissioner or ombudsman, if required or helpful, on how to conduct a privacy impact assessment. å Be vigilant about addressing security and privacy issues both when an erecord system is implemented and on an ongoing basis. Issues such as physical security, secure backup of records, and the periodic review and updating of policies and training remain important considerations. å Conduct periodic privacy audits of the EMR system to ensure it continues to comply with privacy obligations. As with paper records, physicians have an ethical and legal obligation to keep all patient information confidential. However, when patient information is stored in a shared erecord, it is likely accessible to a greater number of people than a traditional paper record and as a result protection is more complex. Robust security features and policies must ensure information in an erecord is only accessible within the circle of care to provide patient care, or for other purposes that are authorized by law or with the express consent of the patient. This can be achieved through the use of secure login protocols. In addition to having security mechanisms that limit access to authorized persons only, where possible it is prudent to consider equipping the erecord system with controls that restrict access based on the user s role and responsibilities. Locating printers and fax machines in areas with restricted access, having an automatic feature that logs the user out after a period Electronic Records Handbook 15

16 of inactivity, and installing anti-virus, malware, and spyware software are other ways to protect patient information. Consult with the system vendor or provincial, territorial, or national medical associations for assistance in choosing appropriate security features. In addition to addressing security and privacy issues when an erecord system is implemented, it is equally important to ensure that these same issues are periodically assessed and revised, as necessary. The physical security, secure backup of records, and the periodic review and updating of policies and training remain important even after an erecord system is implemented. The CMPA strongly recommends that physicians consider implementing encryption protection on all computer systems (including desktops and laptops) containing personal health information. Those who store patient information on portable data storage devices such as tablets, smartphones, USB flash drives, and portable hard drives should also consider installing encryption software on these devices. Some privacy commissioners and Colleges have stated that physicians and other custodians must encrypt patient information stored on mobile devices. As new technologies evolve, physicians should continue to consult vendors and privacy commissioners, among others, about the appropriate degree of security. When using a wireless network to access and send patient information contained in an erecord, physicians should consider how to ensure that the network is secure. Particular caution should be paid to remotely accessing erecords using a wireless device, including smartphones and tablets. Appropriate security controls should be installed on mobile devices and wireless networks to prevent unauthorized access to erecords. Additional requirements may apply when transmitting a patient s personal health information outside of the province or territory where it was collected. For example, patient notification may be required when using a service provider outside of Canada for transcription of dictation. Privacy impact assessments and audits Some jurisdictions require a privacy impact assessment before changes are made to an EMR system. While the assessment may not be a legal requirement in every jurisdiction, it is a prudent and valuable procedure. These assessments identify and minimize the privacy risks associated with the implementation of the EMR system. Physicians are encouraged to consult with their privacy commissioner or ombudsman on how to conduct a privacy impact assessment. Some privacy commissioners have published guidelines. In some jurisdictions, it may be necessary to submit the completed privacy impact assessment to the privacy commissioner for review and comment. Once the EMR system is installed, it is prudent for practitioners to periodically conduct privacy audits. These ensure that access to patient records in the erecord has been restricted to authorized individuals for authorized purposes. With regular audits, unauthorized access can be identified early and managed appropriately (see the following section, Maintaining data integrity, for further discussion of audits). Transportation of data There are risks with physically transporting electronically stored personal health information. The Canada Border Services Agency and some foreign governments have stated they have unequivocal authority to search and potentially seize electronic devices that a traveller may be attempting to bring into the country. In some cases, information obtained in a border search may be broadly shared. Obviously, this raises concerns for the privacy and security of patients personal health information that is stored on a device and subjected to a border search. Members are encouraged to contact the CMPA before physically transporting or electronically transmitting health information across borders. 16 Electronic Records Handbook The Canadian Medical Protective Association

17 Maintaining data integrity å Ensure the erecord has an audit trail that clearly indicates alterations but does not obscure the original record. Comply with applicable policies, by-laws, or regulations that stipulate audit trail functionality. å Back up electronic patient information, possibly daily or weekly. å All healthcare providers using the erecord, especially in a shared erecord environment, should make reasonable efforts to know who contributes to it and how often it is being accessed. å In the event of a legal proceeding, physicians employing an electronic signature device will want to be able to explain how the device works and attest to its reliability. Physicians have a legal obligation and professional duty to their patients to keep records that are accurate, complete, and up-to-date. With electronic record systems, physicians must ensure the authenticity and integrity of both the electronic data and the process by which it was created. Some measures may be required by legislation or by the Colleges. Audit trails An erecord should have an audit trail detailing who accessed the record, their activities, and any alterations. The audit helps demonstrate that the information is authentic and reliable by providing a technical log of the activity in the record through the creation of metadata. Electronic Records Handbook 17

18 Physicians should comply with all applicable policies, by-laws, or regulations that stipulate the audit trail functionality. Generally, the system should enable the physician to: identify who has accessed the record identify what, if any, alterations have been made identify who made a specific alteration and when print and view a copy of the unedited, original version of the record (any amendments should be separately visible without permanently deleting the original entry) demonstrate that the chain of custody of the record or entry is sound Editing, deleting, correcting records Physicians have a responsibility to maintain accurate records. Fulfilling this responsibility includes complying with requests from patients seeking access to their record. Patients have the right to access their records and to request a correction or amendment. These requests should be reasonably accommodated. Physicians, however, are generally entitled to refuse requests to correct medical opinions or information that is necessary for clinical purposes. The decision must be made on a case-by-case basis and in keeping with any applicable legislation or College requirements. For example, privacy legislation may set timelines for responding to patient requests, establish parameters for granting or refusing correction requests, identify how the record is to be amended, and require certain steps be taken once a request is granted or refused. Doctors should be familiar with those provisions and comply with them. Physicians should also be aware that multiple healthcare providers may be treating the patient and making entries into the erecord. If a patient requests that the physician correct or amend an entry made by another healthcare provider, it would be prudent to direct the patient s request to that provider. If the entry is relevant to the treatment the doctor is providing or has provided to the patient, the doctor may consult with the other healthcare provider to determine whether the change should be made and by whom. If refusing a patient s request for a change, physicians should keep the following in the record: a copy of the request, the letter of refusal setting out the reasons for refusing, and any communications received or sent via or other electronic means. Some privacy legislation also requires that physicians retain copies of any letters of disagreement the patient sends upon learning of a refusal. Physicians are encouraged to contact the CMPA for assistance in these circumstances. Physicians also have a general duty to correct inaccurate information in a patient s record, especially when the information is vital to the patient s treatment. If a doctor believes the record must be changed, as much as possible the amendment should be made in accordance with applicable College requirements. It should not obscure or delete the original entry. In an electronic environment, changes can usually be made using an addendum or digital strikeout. The date, time, and initials (or electronic signature) of the person making the alteration should be visible on the electronic record. A track changes function (similar to that found in most word processing programs to monitor changes to documents) could be used. When this is not available, an addendum should be placed in the record explaining what change is needed, preferably next to the original entry, if possible. Notifying other users of erroneous or outdated information If physicians become aware that an erecord to which they have access contains outdated, incomplete, or inaccurate information of clinical significance, it is prudent to alert other users within a reasonable time so the patient s treatment is not compromised. Then, physicians should try to correct the erroneous information as soon as possible. Changes should be made in accordance with College requirements. 18 Electronic Records Handbook The Canadian Medical Protective Association

19 Doctors should also be aware that privacy legislation generally requires custodians who correct records to notify others to whom the relevant information has been disclosed. The data sharing agreement should ideally contain a provision that addresses the procedures for correcting the erecord and requiring notification of previously accessed erroneous or outdated information. Receiving data or records from other healthcare providers A unique challenge with EHRs (and shared EMRs) is that other healthcare providers have access to the data and may contribute to the erecord directly. A physician may also receive data or records from other healthcare providers that are incorporated into a patient s EMR. These physicians may be unfamiliar with each other s practices and may not consult with each other regularly, if at all. The importance of accuracy is increased in these circumstances and all healthcare providers using the erecord should make reasonable efforts to know who contributes to it, how often it is being accessed, and how information they have added should appear on the screen or printout (e.g. initialed or signed and dated entries, strikeouts, and addendums for changes to original entries, etc.). Converting paper records to electronic form Physicians who choose to adopt an EMR might question whether their existing paper records should be transferred to an electronic format and whether, once scanned, the original records can be destroyed. Documents converted into electronic format are considered copies. However, they are nonetheless generally admissible in legal proceedings. The rules concerning the admissibility of copies have been modified in most Canadian jurisdictions to take into account the reality of electronic record-keeping. Responding to a legal request to produce an electronic record can be challenging. It may be necessary to produce the metadata embedded in all electronic documents, including the audit trail, records of key strokes and deletions, and decision support information. Specialized technical assistance may be needed to ensure that all the required data is included. Upon receiving a subpoena or a court order to produce medical records (in paper or electronic form), physicians are encouraged to contact the CMPA for advice. Most, if not all, Colleges permit the destruction of paper records once they have been appropriately scanned. However, the CMPA encourages physicians to consider the following guidance to ensure paper records converted into electronic format meet the legal requirements: An experienced and reputable commercial organization may assist in establishing procedures for the conversion. The conversion should take place in a consistent and careful manner, with appropriate safeguards so as to ensure the digital copies are sufficiently reliable. Written procedures should be established and consistently followed for the conversion process (including a record of the type of conversion process used), with the physician keeping a copy of these procedures. The process should involve some form of quality assurance (e.g. comparing the digital copy to the original to ensure the information has been accurately converted), and a record should be kept of the quality assurance steps taken with respect to each document. Scanned records should be kept in read-only format so they cannot be altered or manipulated after conversion. Physicians should be aware of the differences between scanning and optical character recognition. Scanning simply generates a non-editable digital representation of an image whereas optical character recognition (OCR) is a technology process that converts an image of handwritten or typewritten text into machine-editable text. Once an image has been converted using OCR, the text can be changed, Electronic Records Handbook 19

20 searched, or otherwise manipulated. OCR may be used in conjunction with scanning. However, OCR alone should not be used when converting paper records to electronic form, unless the original paper records will also be scanned or will be maintained in paper form. When the appropriate steps have been taken, it may be reasonable for practitioners to destroy the original record. However, in exceptional cases, such as when the quality of the paper records makes the converted document difficult to read, it may be prudent to retain the paper records for at least the period of retention recommended by the CMPA: at least 10 years from the date of the last entry or, in the case of minors, 10 years from the date on which the minor reaches the age of majority. Physicians should be aware that Colleges in some jurisdictions have adopted lengthier retention periods to reflect changes in the limitation periods for the commencement of medical malpractice actions. In those jurisdictions physicians are encouraged to retain records for a longer period to reflect those limitation periods. The eventual destruction of the paper records should be in keeping with the physician s obligation of confidentiality as well as any applicable legislative and College requirements. Physicians should contact the CMPA with any questions they may have about the applicable requirements in their jurisdiction. Data migration Physicians who are already using an EMR and wish to switch to a new EMR software or vendor will need to consider how to maintain the integrity of the patient data as entered in the old EMR system. Options may include migrating the data from the old system into the new system or archiving the data in the old system. Regardless of the process, physicians will want to ensure they have continued access to their patients data for the applicable retention period and that the information, including the metadata, is not compromised or otherwise changed in the process. This can be a challenging and labour intensive process, so physicians may wish to consult with IT professionals and their system vendor. Backup and recovery It is not uncommon for computer systems to fail, which can lead to the loss of patient information contained in an EMR. In some jurisdictions, legislation and regulatory authority policies require that electronic files are routinely backed-up and that the system allows files to be recovered. Even if there are no specific regulatory requirements in a particular jurisdiction, it is a good practice to back up patient information daily or weekly and to ensure the backup files are encrypted. Physicians may also want to regularly test the restore process for these backed up files. Furthermore, they may wish to use an off-site backup system to protect patient records, in case an office computer is stolen, lost, or destroyed. An example of such an off-site system is the use of cloud computing technology to deliver backup services 20 Electronic Records Handbook The Canadian Medical Protective Association

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